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Found 10105 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:527002 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2014-03-28
Location:Foreign  Entered:2014-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0979727A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR  SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  SCUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of febrile convulsion in an infant female subject who was vaccinated with ROTARIX (GlaxoSmithKline), ACTHIB (non-gsk) and PREVENAR 13 (non-gsk). On an unspecified date, the subject received an unspecified dose of ROTARIX (oral), an unspecified dose of ACTHIB (subcutaneous, unknown) and an unspecified dose of PREVENAR 13 (subcutaneous, unknown). At an unspecified time after vaccination with ACTHIB, PREVENAR 13 and ROTARIX, the subject experienced febrile convulsion. The pharmacist considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were resolved.

VAERS ID:527098 (history)  Vaccinated:2013-10-02
Age:0.3  Onset:2014-01-04, Days after vaccination: 94
Gender:Female  Submitted:2014-03-28, Days after onset: 82
Location:Foreign  Entered:2014-03-28
Life Threatening? No
Died? Yes
   Date died: 2014-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: The patient was diagnosed at US-intussusception. Air enema was successful. Another ultrasound was performed and the result was ok.
CDC Split Type: WAES1403ISR012065
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0169090PO 
Administered by: Other     Purchased by: Other
Symptoms: Constipation, Cyanosis, Enema administration, Intussusception, Pallor, Somnolence, Sudden infant death syndrome, Urine output decreased, Vomiting
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad)
Write-up: This spontaneous report as received from via an agency from a physician refers to a 4 month old female patient who on 02-OCT-2013, was vaccinated with the first dose of ROTATEQ lot # H016909, Exp. Date: 30-JUN-2014, oral (dose not reported). Concomitant therapies included PREVENAR and DTaP/Hib and IPV (unspecified). It was reported that on 10-NOV-2013, the patient was admitted in the hospital due to three days of vomiting and constipation. According to her parents she also had less urine than usual. There was no fever. According to the mother the baby was sleepy. The patient was diagnosed at US-intussusception. Air enema was successful. Another ultrasound was performed and the result was ok. The baby was released from the hospital on 11-NOV-2013. The baby died on 04-JAN-2014. The mother got up from her sleep and went to the baby. The baby was pale with blue spots on the face. Classification after death was sudden infant death syndrome (SIDS). The related ness for intussusception and sudden infant death syndrome (SIDS) and ROTATEQ was unknown. Additional information has been requested.

VAERS ID:526888 (history)  Vaccinated:2012-06-01
Age:1.0  Onset:2014-03-19, Days after vaccination: 656
Gender:Male  Submitted:2014-03-26, Days after onset: 7
Location:Arizona  Entered:2014-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Virus culture: VZV/HSV w/DFA. Source: skin. Positive for varicella zoster virus by direct fluorescent antibody stain.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB515BA0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1404AA0SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169583IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0669AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash, Varicella post vaccine, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt. developed a rash 3-19-14. 3-22-14. He was seen at urgent care 3-22-14. They did a VZV/HSV w/DFA - skin scraping. Resulted 3-26-14: Positive for varicella zoster. Was reported to state dept of health services 3-27-14.

VAERS ID:526911 (history)  Vaccinated:2014-03-21
Age:0.2  Onset:2014-03-23, Days after vaccination: 2
Gender:Female  Submitted:2014-03-27, Days after onset: 4
Location:California  Entered:2014-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Several weeks prior to vaccination, she had had 2 episodes of blood-tinged stools. (Mom had tried a lactagogue supplement herself, and baby had blood-tinged stool. She stopped it and stool normalized. Mom took it again once more and baby had blood-tinged stool again. Mom discontinued it for good and no further blood-tinged stool until current episode).
Diagnostic Lab Data: N/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSF35420IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH972AB0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH419470IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB24A0PO 
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Blood-tinged stool (specks) started 2 days after receiving routine 2 month old vaccines, including Rotarix (RV1). By 3/27/14 (today), still present. No vomiting, no current-jelly stools, feeding well, no pain or fussiness, otherwise normal exam. Clinically not acting like intussusception -- just blood-specked stools. (This could very well be cows-milk sensitivity, so will restrict cow and soy products from mom''s diet [nursing] and change to elemental formula.)

VAERS ID:526915 (history)  Vaccinated:2009-05-27
Age:1.6  Onset:2010-02-01, Days after vaccination: 250
Gender:Male  Submitted:2014-03-27, Days after onset: 1514
Location:Texas  Entered:2014-03-27
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Patient has undergone numerous speech and developmental therapies for his condition.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1605Y0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0376Y0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHD332453IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0376Y0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Aggression, Autism, Coordination abnormal, Developmental delay, Incorrect dose administered, Mobility decreased, Motor dysfunction, Vaccination complication
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow)
Write-up: Slow regression in movement, coordination, and motor functioning. Later diagnosed with high functioning autism. I distinctly remember the office being in a transition with medical records going to a more computerized system. I believe my son was 1. Had a bad reaction to the vaccine. 2. Was given the MMR vaccination twice.

VAERS ID:526849 (history)  Vaccinated:2013-10-28
Age:0.4  Onset:2013-10-31, Days after vaccination: 3
Gender:Male  Submitted:2014-03-26, Days after onset: 146
Location:Foreign  Entered:2014-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2014081855
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURJO172 UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH933995 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This is a spontaneous report from a contactable consumer via the Regulatory Authority received under reference number: GB-MHRA-ADR 22457069. A 5-month-old male patient received PREVENAR 13 (Lot #933995), PEDIACEL (Lot#Jo172) and MENINGOCOCCAL C VACCINE, all parenteral on 28Oct2013. Relevant medical history and concomitant medications were unknown. On 31Oct2013, the patient experienced a cluster of seizures. The outcome of the event was recovered on 01Nov2013. The reporter considered the event to be serious as it involved hospitalisation. The regulatory authority considered the event to be serious for an unspecified reason. No follow-up attempts possible. No further information expected.

VAERS ID:526855 (history)  Vaccinated:2014-02-26
Age:  Onset:0000-00-00
Gender:Male  Submitted:2014-03-26
Location:Foreign  Entered:2014-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Body temperature, elevated
CDC Split Type: 2014082953
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Erythema, Haematoma, Limb immobilisation, Local swelling, Mood altered
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: This is a spontaneous report from a non-clinical study program, from a contactable consumer. A male patient of an unspecified age and ethnicity received PREVENAR 13, via an unspecified route of administration on 26Feb2014 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced haematoma, immobilized arm, low appetite for two weeks, temperature elevation, weakness, swelling arm, redness arm, and bad mood all on an unspecified date. Therapeutic measures included "anti inflammation tablets" and then REDOXON. The patient referred he does not have physician.

VAERS ID:526856 (history)  Vaccinated:0000-00-00
Age:1.7  Onset:0000-00-00
Gender:Female  Submitted:2014-03-26
Location:Foreign  Entered:2014-03-27, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2014082837
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Pneumococcal infection
SMQs:
Write-up: This is a spontaneous report from a contactable physician via a sales representative. A 20-months-old female patient of an unspecified ethnicity, received four doses of PREVENAR 13 via an unspecified route of administration, on an unspecified dates, at single doses. The patient medical history and concomitant medications were not reported. The patient experienced infectious process by pneumococcus identified as etiologic agent (serotype 3) on an unspecified date. The patient died as a consequence of the event on an unspecified date. It was not reported if an autopsy was performed.

VAERS ID:526858 (history)  Vaccinated:2012-08-16
Age:0.3  Onset:2012-08-16, Days after vaccination: 0
Gender:Female  Submitted:2014-03-26, Days after onset: 587
Location:Foreign  Entered:2014-03-27, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2014080061
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CBC16A0UNLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF935110UNLG
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apathy, Somnolence, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report received from the foreign health authority. Regulatory Authority report number DE-PEI-PEI2014018891. A physician reported that a 3-month-old female patient was vaccinated on 16Aug2012 with the first dose of INFANRIX HEXA (lot number A21CBC16A) at 1 DF and with the first dose of PREVENAR 13 (lot number F93511) at 0.5 ml single dose, in thigh, route of administration not reported. The patient medical history and concomitant medications were not reported. On 16Aug2012, 1 hour after vaccination the patient was suddenly apathetic, had a bloated face and an increased desire to sleep. The events required ambulatory treatment and were reported to have been "lasting for 3 days." The outcome of the events was unknown at the date of reporting. The reporter assessed the case as potentially life-threatening. Causal relationship was not reported. No follow-up attempts possible. No further information expected.

VAERS ID:526859 (history)  Vaccinated:0000-00-00
Age:1.5  Onset:0000-00-00
Gender:Female  Submitted:2014-03-26
Location:Foreign  Entered:2014-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood culture, bacteremia; Blood culture, HUS; Serology test, 19A
CDC Split Type: 2014080318
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG793943UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, Empyema, Haemolytic uraemic syndrome, Pneumococcal bacteraemia, Streptococcus test positive
SMQs:, Haemolytic disorders (narrow), Renovascular disorders (broad), Chronic kidney disease (broad)
Write-up: This is a spontaneous report from a contactable physician. A 24-month-old female patient of an unspecified ethnicity received the fourth dose of PREVENAR 13 (lot G79394) at 18 months of age. Previously, PREVENAR 13 was administered on unspecified dates at the age of 3 months (first dose, lot number F65189), at the age of 5 months (second dose, lot number F65189), and at the age of 7 months (third dose, lot number F89734). Dosage regimen was 0.5 ml single dose each time. Route of administration was not provided. The patient medical history and concomitant medications were not reported. On an unspecified date in 2013 the patient experienced bacteraemia with focus (pneumonia), pleura empyema and hemolytic-uremic syndrome. The patient underwent lab tests and procedures which included serology test: serotype 19A. Blood culture and thoracic empyema probe were used for microbiological examinations. It was reported that the patient recovered with sequelae on an unknown date. No follow-up attempts possible. No further information expected.

VAERS ID:526860 (history)  Vaccinated:0000-00-00
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2014-03-26
Location:Foreign  Entered:2014-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PREVENAR 13, first dose, age: 3 months, lot number: G43561; PREVENAR 13, second dose, age: 5 months, lot number G43562
Diagnostic Lab Data: Blood culture, pneum. meningitis; CSF culture, pneum. meningitis; Serology test, serotype 10A
CDC Split Type: 2014080302
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF923342UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, CSF culture positive, Meningitis pneumococcal, Otitis media, Pneumococcal bacteraemia, Streptococcus test positive
SMQs:
Write-up: This is a spontaneous report from a contactable physician. A 13-month-old male patient of an unspecified ethnicity received the third dose of PREVENAR 13 at 0.5 ml single dose at the age of 6 months (lot no.: F92334). First dose of PREVENAR 13 was administered at the age of 3 months (lot no.: G43561) and the second dose was administered at the age of 5 months (lot no.: G43562). Patient was not a former preterm and had no immunodeficiency and no chronic diseases. The patient''s concomitant medications were not reported. The patient experienced pneumococcal meningitis, pneumococcal bacteraemia without focus and otitis media with effusion on an unspecified date in 2013 with unknown outcome. Complete recovery was unclear. Pathogen mater al was liquor and blood culture. Serotype was provided as 10A. The patient did not die. No follow-up attempts possible. No further information expected.

VAERS ID:526861 (history)  Vaccinated:0000-00-00
Age:1.3  Onset:0000-00-00
Gender:Female  Submitted:2014-03-26
Location:Foreign  Entered:2014-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PREVENAR 13, first dose lot# F40144-age of 2 months; PREVENAR 13, second dose lot# F40144-age of 3 months; PREVENAR 13, third dose lot# F43126-age of 5 months
Diagnostic Lab Data: Blood culture, S. pneumoniae; Serology test, serotype 33F
CDC Split Type: 2014080327
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF636923UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Meningitis pneumococcal, Streptococcus test positive
SMQs:
Write-up: This is a spontaneous report from a contactable physician. A 29-month-old female patient of an unspecified ethnicity received 4 doses of PREVENAR 13 vaccinations: 1st dose (lot# F40144) at the age of 2 months, 2nd dose (lot# F40144) at the age of 3 months; 3rd dose (lot# F43126) at the age of 5 months and 4th dose (lot# F63692) at the age of 15 months, dates unspecified. Dose regimen was at 0.5 ml single dose each time. Route of administration was not provided. Concomitant medication was not provided by reporter. The patient medical history showed no chronic diseases, immune defects and stated that the child wasn''t a premature baby. At the age of 29-months in 2014 the patient experienced pneumococcal meningitis with serotype 33F. The patient underwent lab tests and procedures which included serology test: serotype 33F. Streptococcus pneumoniae was detected in blood culture. Outcome was recovered in 2014. No follow-up attempts possible. No further information expected.

VAERS ID:526786 (history)  Vaccinated:2014-03-14
Age:0.6  Onset:2014-03-17, Days after vaccination: 3
Gender:Male  Submitted:2014-03-26, Days after onset: 9
Location:Utah  Entered:2014-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4658AA2IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.J0103352IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH506032IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0085072PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: 103 degree fever x 3 days.

VAERS ID:526788 (history)  Vaccinated:2014-03-19
Age:0.4  Onset:2014-03-24, Days after vaccination: 5
Gender:Male  Submitted:2014-03-26, Days after onset: 2
Location:New York  Entered:2014-03-26
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH972AB0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG624340IMRL
Administered by: Public     Purchased by: Public
Symptoms: Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad)
Write-up: Pt seen at ED on 03/24/2014, transferred to another hospital, admitted on 03/25/14 at 1:00 AM for respiratory distress MD plans on discharge 03/26 or when a safe discharge plan is in place.

VAERS ID:526791 (history)  Vaccinated:2014-03-24
Age:1.4  Onset:2014-03-25, Days after vaccination: 1
Gender:Male  Submitted:2014-03-26, Days after onset: 1
Location:Texas  Entered:2014-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Normal CBC and CMP. Negative rapid strep and flu tests. Normal throat culture. Blood culture negative to date.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4663AA3IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH506033IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood culture negative, Crying, Culture throat negative, Full blood count normal, Gait disturbance, Influenza virus test negative, Metabolic function test normal, Pyrexia, Rash erythematous, Streptococcus test negative
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Crying that lasted over 12 hours; refusal to walk for 24 hours; erythematous rash for 12-24 hours; fever to 104 for 24 hours.

VAERS ID:526807 (history)  Vaccinated:2014-03-20
Age:0.4  Onset:2014-03-20, Days after vaccination: 0
Gender:Male  Submitted:2014-03-26, Days after onset: 6
Location:South Dakota  Entered:2014-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS7537C1IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J0080911IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH001371IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSJ0083641PO 
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever 100.4. Seizure evening of vaccine.

VAERS ID:526715 (history)  Vaccinated:2014-02-25
Age:0.3  Onset:2014-02-28, Days after vaccination: 3
Gender:Female  Submitted:2014-03-25, Days after onset: 24
Location:Foreign  Entered:2014-03-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: Herpes virus antibody (02-MAR-2014): no increase; Varicella virus antibody (02-MAR-2014): no increase; Epstein-Barr virus antibody (02-MAR-2014): no increase
CDC Split Type: WAES1403JPN011340
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURERA007B1UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURJ15862UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH13E01B2UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0218561PO 
Administered by: Other     Purchased by: Other
Symptoms: Blister, Epstein-Barr virus antibody negative, Erythema, Erythema nodosum, Pyrexia, Swelling face, Viral titre
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Initial information has been received from a physician via the Pharmaceutical and Medical Devices Agency (PMDA) concerning a 4 months old female patient who on 25-FEB-2014 received the third unspecified dose of oral ROTATEQ (lot no.: H021856, expiration date: 01-OCT-2014). According to the medical history interview sheet (underlying disease, allergy, history of vaccination/disease during the recent one month, medications currently taking, past history of adverse reaction, status of growth etc.), the patient had no problem. The patient also had no family history. The body weight at birth was 2944 g. Other suspected drugs included simultaneous vaccination of DTP-IPV injection drug (second dose, date of vaccination: 25-FEB-2014, dose: unknown, indication: unknown, lot no.: A007B), ACTHIB injection drug (third dose, date of vaccination: 25-FEB-2014, dose: unknown, indication: unknown, lot no.: J1586), and PREVENAR 13 injection drug (third dose, date of vaccination: 25-FEB-2014, dose: unknown, indication: unknown, lot no.: 13E01B). There were no other concomitant medications. On an unspecified date, the patient was vaccinated with the first unspecified dose of ROTATEQ. On 25-FEB-2014, the patient was simultaneously vaccinated with the second dose of ROTATEQ, DTP-IPV (first phase, second dose), ACTHIB (first phase, third dose), and PREVNAR 13 (first phase, third dose) at clinic. After receiving the simultaneous vaccination with the 4 vaccines, the patient developed pyrexia on the same day, which persisted for 2 days (the pyrexia resolved on 27-FEB-2014). On 28-FEB-2014, multiple erythema developed not only on the three vaccination sites but also on both upper and lower limbs, some of which were raised accompanied with blisters, and were accumulated and scattered. On around 02-MAR-2014, redness of face and swelling face were also noted. No increase in antibodies of herpes, varicella, and Epstein-Barr (EB) virus was observed. After 04-MAR-2014, the erythema showed a tendency of resolving. On 11-MAR-2014, multiple erythema nodosum was recovering/resolving. At the time of the report, the outcome of redness of face and swelling face was unknown. The reporter''s comment: Although the patient was in a good general condition, the case was reported because the erythema was severe and its appearance was not localized. The reporting physician considered multiple erythema nodosum as serious due to other important medical condition and did not assess the seriousness of pyrexia, redness of face and swelling face. The reporting physician felt that multiple erythema nodosum was related to ROTATEQ, DTP-IPV, ACTHIB and PREVNAR 13. The reporting physician did not assess the causal relationship of pyrexia, redness of face and swelling face to ROTATEQ. Additional information is not expected.

VAERS ID:526726 (history)  Vaccinated:0000-00-00
Age:75.0  Onset:0000-00-00
Gender:Female  Submitted:2014-03-25
Location:Foreign  Entered:2014-03-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Thyroidectomy; Acute renal failure; Hypercalcemia
Diagnostic Lab Data: MAR-2014, Body temperature, 38 Centigrade
CDC Split Type: 2014080151
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Gait disturbance, Hyporeflexia, Injection site erythema, Injection site induration, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)
Write-up: This is a spontaneous report from a contactable physician via a medical advisor. A 75-year-old female patient received PREVENAR 13, intramuscular, on an unspecified date in Mar2014 at 0.5 ml single. Relevant medical history included ongoing thyroidectomy, ongoing renal failure acute and ongoing hypercalcaemia (start dates unknown). The patient''s concomitant medications were not reported. The day after the vaccination (Mar2014) the patient experienced injection site redness, injection site induration, muscular weakness, dizziness, gait instability, reduced reflexes and fever (38 Centigrade). The patient was admitted to a private clinic on 18Mar2014. Fever resolved one day after its onset (Mar2014) while the other adverse events were not resolved.

VAERS ID:526727 (history)  Vaccinated:2014-03-17
Age:0.2  Onset:2014-03-17, Days after vaccination: 0
Gender:Male  Submitted:2014-03-25, Days after onset: 8
Location:Foreign  Entered:2014-03-26, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2014-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown, Premature delivery at 30th week; Unknown, Respiratory failure at birth
Diagnostic Lab Data:
CDC Split Type: 2014081374
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB938A0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH508500UNRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)
Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 242813. A hospital physician (contactable through Regulatory Authority only) referred that a 9-week-old male patient received on 17Mar2014 at 09:30 first dose of PREVENAR 13 (Lot n. H50850 expiration date 31Jul3015) via an unspecified route of administration in the right thigh and first dose of INFANRIX HEXA (Lot n. A21CB938A expiration date 31May0215) via an unspecified route of administration in the left thigh. Medical history included premature delivery (at 30th week). respiratory failure (at birth), 2.9 kg weight at birth. The patient''s concomitant medications were not reported. The patient experienced sudden death on 17Mar2014. At 14:30 patient''s mother was not hearing patient''s breath and therefore carried by its own means the patient to the emergency room. The patient died on 17Mar2014. It was unknown if an autopsy was performed.

VAERS ID:526728 (history)  Vaccinated:2014-01-09
Age:53.0  Onset:0000-00-00
Gender:Male  Submitted:2014-03-25
Location:Foreign  Entered:2014-03-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Acute leukemia; Transplant
Diagnostic Lab Data:
CDC Split Type: 2014079138
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Aspergillus infection, Bronchospasm
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report from a contactable physician via Pfizer sales representative. The physician reported events for the same patient after the first and second dose of vaccine received. This is the case reporting events after the first dose. A 53-year-old male patient received the first dose of PREVENAR 13 on 09Jan2014, at 0.5 ml single and ACT-HIB on 09Jan2014, single dose. The patient''s medical history included acute leukemia and allograft. Concomitant treatments were not reported. On an unspecified time after vaccination, the patient experienced bronchospasm followed by "quite serious" aspergillosis for 2-3 days. Therapeutic measures taken in response to the events were unknown. The patient recovered from aspergillosis, while outcome of bronchospasm was unknown at the time of the report.

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